Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Glabellar Lines
• Intervention / Treatment: Biological: ATGC-100; Biological: Botox®

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Nowon Eulji Medical Center, Eulji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males and females aged between 19 to 65 years old
2. Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
3. Subjects who voluntarily signed the informed consent

Exclusion Criteria:

1. Subjects with general neuromuscular synaptic disorders
2. Presence or history of eyelid and/or ptosis
3. Subjects with noticeable facial asymmetry
4. Inability to substantially lessen glabellar frown lines even by physically spreading apart
5. Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics
6. Subjects who are taking Anti-Coagulant and Anti-Platelet agent
7. Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug
8. Subjects with skin disorders at the injection site
9. Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region
10. Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment
11. Any other planned facial aesthetic procedure in the glabellar area during the trial period
12. Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period
13. A history of drug or alcohol abuse
14. Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATGC-100 (Phase I/II); ATGC-100 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)	Biological: ATGC-100; Clostridium Botulinum Type A
Active Comparator: Botox® (Phase II); Botox® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)	Biological: Botox®; Clostridium Botulinum Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)	Up tp 12 weeks
Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)	4 weeks after the injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)	8, 12 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II)	4, 8, 12 weeks after the injection
Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II)	4, 8, 12 weeks after the injection
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)	Up tp 12 weeks

Collaborators and Investigators

• Sponsor: EuBiologics Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): December 23, 2019

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CBA-PLN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No